{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T00:41:04Z","timestamp":1793320864102,"version":"4.5.0"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T00:00:00Z","timestamp":1771632000000},"content-version":"vor","delay-in-days":1392,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Lungpacer Medical Inc"},{"name":"Lungpacer Medical Inc"}],"content-domain":{"domain":["www.atsjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,5,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Diaphragm dysfunction is frequently observed in critically ill patients with difficult weaning from mechanical ventilation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the effects of temporary transvenous diaphragm neurostimulation on weaning outcome and maximal inspiratory pressure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Multicenter, open-label, randomized, controlled study. Patients aged \u2a7e18 years on invasive mechanical ventilation for \u2a7e4 days and having failed at least two weaning attempts received temporary transvenous diaphragm neurostimulation using a multielectrode stimulating central venous catheter (bilateral phrenic stimulation) and standard of care (treatment) (n\u2009=\u200957) or standard of care (control) (n\u2009=\u200955). In seven patients, the catheter could not be inserted, and in seven others, pacing therapy could not be delivered; consequently, data were available for 43 patients. The primary outcome was the proportion of patients successfully weaned. Other endpoints were mechanical ventilation duration, 30-day survival, maximal inspiratory pressure, diaphragm-thickening fraction, adverse events, and stimulation-related pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements and Main Results<\/jats:title>\n                    <jats:p>The incidences of successful weaning were 82% (treatment) and 74% (control) (absolute difference [95% confidence interval (CI)], 7% [\u221210 to 25]), P\u2009=\u20090.59. Mechanical ventilation duration (mean\u2009\u00b1\u2009SD) was 12.7\u2009\u00b1\u20099.9 days and 14.1\u2009\u00b1\u200910.8 days, respectively, P\u2009=\u20090.50; maximal inspiratory pressure increased by 16.6 cm H2O and 4.8 cm H2O, respectively (difference [95% CI], 11.8 [5 to 19]), P\u2009=\u20090.001; and right hemidiaphragm thickening fraction during unassisted spontaneous breathing was +17% and \u221214%, respectively, P\u2009=\u20090.006, without correlation with changes in maximal inspiratory pressure. Serious adverse event frequency was similar in both groups. Median stimulation-related pain in the treatment group was 0 (no pain).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Temporary transvenous diaphragm neurostimulation did not increase the proportion of successful weaning from mechanical ventilation. It was associated with a significant increase in maximal inspiratory pressure, suggesting reversal of the course of diaphragm dysfunction.<\/jats:p>\n                    <jats:p>Clinical trial registered with www.clinicaltrials.gov (NCT 03096639) and the European Database on Medical Devices (CIV-17-06-020004).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1164\/rccm.202107-1709oc","type":"journal-article","created":{"date-parts":[[2022,2,2]],"date-time":"2022-02-02T16:29:52Z","timestamp":1643819392000},"page":"1169-1178","update-policy":"https:\/\/doi.org\/10.1164\/crossmarkpolicies","source":"Crossref","is-referenced-by-count":77,"title":["Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients"],"prefix":"10.1093","volume":"205","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9191-6089","authenticated-orcid":false,"given":"Martin","family":"Dres","sequence":"first","affiliation":[{"name":"Experimental and Clinical 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Intensive-R\u00e9animation, H\u00f4pitaux Universitaires de Strasbourg, Nouvel H\u00f4pital Civil, Strasbourg, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holger","family":"M\u00fcller-Redetzky","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Respiratory Medicine, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominic","family":"Dellweg","sequence":"additional","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Fachkrankenhaus Kloster Grafschaft GmbH, Schmallenberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Winfried J.","family":"Randerath","sequence":"additional","affiliation":[{"name":"Institute for Pneumology at the University of Cologne Bethanien Hospital, Clinic for Pneumology and Allergology, Centre of Sleep Medicine and Respiratory Care, Solingen, 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